oxycodone hydrochloride

Generic: oxycodone hydrochloride

Labeler: strides pharma science limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name oxycodone hydrochloride
Generic Name oxycodone hydrochloride
Labeler strides pharma science limited
Dosage Form TABLET
Routes
ORAL
Active Ingredients

oxycodone hydrochloride 5 mg/1

Manufacturer
Strides Pharma Science Limited

Identifiers & Regulatory

Product NDC 64380-259
Product ID 64380-259_226ed432-8e6c-4de6-840c-55c6379f9064
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA077712
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2024-09-10

Pharmacologic Class

Classes
full opioid agonists [moa] opioid agonist [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64380259
Hyphenated Format 64380-259

Supplemental Identifiers

RxCUI
1049611 1049618 1049621 1049683 1049686
UPC
0364380262015 0364380260011 0364380259015 0364380261018 0364380263012
UNII
C1ENJ2TE6C

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name oxycodone hydrochloride (source: ndc)
Generic Name oxycodone hydrochloride (source: ndc)
Application Number ANDA077712 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE, PLASTIC (64380-259-01)
  • 500 TABLET in 1 BOTTLE, PLASTIC (64380-259-02)
source: ndc

Packages (2)

64380-259-01 100 TABLET in 1 BOTTLE, PLASTIC (64380-259-01) 64380-259-02 500 TABLET in 1 BOTTLE, PLASTIC (64380-259-02)

Ingredients (1)

oxycodone hydrochloride (5 mg/1)

Linked Drug Pages (1)

Oxycodone Hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "226ed432-8e6c-4de6-840c-55c6379f9064", "openfda": {"upc": ["0364380262015", "0364380260011", "0364380259015", "0364380261018", "0364380263012"], "unii": ["C1ENJ2TE6C"], "rxcui": ["1049611", "1049618", "1049621", "1049683", "1049686"], "spl_set_id": ["f3116ebf-d72c-4e98-aa50-006be4770c86"], "manufacturer_name": ["Strides Pharma Science Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "100 TABLET in 1 BOTTLE, PLASTIC (64380-259-01)", "package_ndc": "64380-259-01", "marketing_start_date": "20240910"}, {"sample": false, "description": "500 TABLET in 1 BOTTLE, PLASTIC (64380-259-02)", "package_ndc": "64380-259-02", "marketing_start_date": "20240910"}], "brand_name": "Oxycodone Hydrochloride", "product_id": "64380-259_226ed432-8e6c-4de6-840c-55c6379f9064", "dosage_form": "TABLET", "pharm_class": ["Full Opioid Agonists [MoA]", "Opioid Agonist [EPC]"], "product_ndc": "64380-259", "dea_schedule": "CII", "generic_name": "Oxycodone Hydrochloride", "labeler_name": "Strides Pharma Science Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Oxycodone Hydrochloride", "active_ingredients": [{"name": "OXYCODONE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "ANDA077712", "marketing_category": "ANDA", "marketing_start_date": "20240910", "listing_expiration_date": "20271231"}